MAUDE Adverse Event Report: ARC DEVICES LTD. ARC INSTA TEMP NON-TOUCH THERMOMETER

Device Problems Break (1069); Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2017

Event Type  No Answer Provided  

Event Description

I heard a pop and snap kind of noise then something hit the wall in my room with a strong full force.Once i investigated i found a battery on the floor and then i discovered the thermometer which somehow snapped open and shot one of the batteries out.The remaining battery exploded and had the battery interior all over my dresser with some of it oozing out of the battery.

• Brand Name: ARC INSTA TEMP NON-TOUCH THERMOMETER
• Type of Device: ARC INSTA TEMP NON-TOUCH THERMOMETER
• Manufacturer (Section D): ARC DEVICES LTD.
• MDR Report Key: 6660100
• MDR Text Key: 78173315
• Report Number: MW5070575
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR